Electronic Regulatory Submissions Software Systems

In the FDA environment, the concept of change control is closely interweaved with regulatory compliance. FDA-regulated pharmaceutical companies are expected to establish a change control procedure as a way to improve product quality and safety and to ensure compliance. Under the Current Good Manufacturing Practice (CGMP) regulations outlined in 21 CFR Parts 210-211, pharmaceutical companies are required to control any change to established processes – meaning the change has to be recorded, reviewed, and approved by the quality control unit. MasterControl provides electronic regulatory submissions software to help pharmaceutical companies to comply with the regulations accordingly.

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Hundreds of companies around the world use MasterControl to automate core business processes and document management activities to promote collaboration, improve decision making, and accelerate time to market.

The MasterControl's electronic regulatory submissions software is an integrated quality management suite which is also configurable and easy-to-use software solution that helps pharmaceutical companies attain and sustain GMP compliance. Recognizing that validating a software solution (as required by 21 CFR Part 11) is a necessary component in FDA compliance, MasterControl offers full-cycle validation services, including IQ, OQ, and PQ validation tests. MasterControl continuously develops new methods to cut the time involved in validating a system and to make it easier to validate software upgrades, both of which are essential in lowering overall validation cost.

MasterControl's electronic regulatory submissions system is designed to help pharmaceutical manufacturers automate and effectively manage every step of the change control process, from submission through actual implementation, verification, and close of project. Here's how MasterControl can ease some of the major challenges in change control.

FDA Submissions Challenges

MasterControl Submissions Gateway™ Solution

Inefficient Processes

FDA submissions (i.e. for a new drug or investigational drug application) can entail thousands of pages that need to be managed, compiled, published, and revised when necessary. With a paper-based system, the process can be overwhelming and is likely to cause delays and errors.

Efficient Process

MasterControl's electronic regulatory submissions system can be integrated with a company's existing submission tool to streamline and effectively manage the process of electronic submission. MasterControl provides a centralized repository for all regulatory submissions, making search and retrieval easy. MasterControl is Web-based so it's accessible to all authorized users regardless of location.

Lack of Security

21 CFR Part 11 has specific security requirements to ensure the integrity and authenticity of data. Paper submissions compiled in binders and folders or stored partially in computers provide little security. MasterControl offers electronic regulatory submissions software to convert this paper based submissions management to manage them electronically.

Secure Repository

Documents are stored in secure virtual vaults located in a central database for authorized access only. An electronic regulatory submissions system automatically locks both login and approval any time a password or login is compromised. Uses industry-standard SSL and 128-bit encryption capabilities to secure data communications that take place between the Web browser and the application.

Lack of Revision Control

In a paper-based system, there could be multiple (unwanted) versions of documents. Modifying a document entails time-consuming meetings and manual change.

Automatic Revision Control

MasterControl's "check out" and "check in" feature in the electronic regulatory submissions software provides automatic revision control to ensure that only the current version of a document is available. When a user makes a change in the InfoCard (the MasterControl tool that provides basic information for every record), the user must enter a reason for the change. The system tracks these changes and makes them available through reports.

Features of Electronic Regulatory Submission Systems

Change control is a complex process, but MasterControl's robust solution can help pharmaceutical manufacturers standardize and simplify change control procedures and electronic regulatory submissions system in order to increase efficiency and effectiveness. MasterControl Change Control includes:

Best-Practice Form – A pre-configured, multi-page form helps collect and track data every step of the way in the change control process: submission, evaluation, approval/rejection, implementation, verification, and close of project.

A section in the change submission form captures such information as: description of change, justification, and impact. Both original and revised documents can be attached for easy comparison.

An initiator can use one form in the electronic regulatory submissions software for multiple changes, depending on how many documents/items are affected by a change. For example, the form for a change in a component used in making 10 products can have 10 attachments, greatly streamlining the process.

The initiator is asked to evaluate the change in terms of training, validation, and regulatory requirements, prompting risk assessment. It also asks for classification of the change as low, medium, and high. Any high-level change implies great impact on the product and is likely to require regulatory filing.

The ability to prioritize is incorporated within the electronic regulatory submissions system because the form asks the initiator to categorize the change submission as routine or temporary or emergency.

Additional forms can be customized based on the company's special needs.

Form-to-Form Launching – A change submission form can be launched directly from a Corrective/Preventive Action (CAPA) form, connecting one electronic regulatory submissions system to the next. Not only does MasterControl streamline this process, but it also maintains the links so one can review a completed process and easily see what triggered the change. Relevant information from the CAPA form will be automatically entered into the change submission form, reducing data entry. It also shows the history of the entire process.

Document Approval via Forms – The change submission form and the documents linked to it can be approved all at once, avoiding repetitive steps.

Dependent Routing – Completion of a task can be made from the electronic regulatory submissions software dependent on another task to give managers more control and reduce cycle time by prompting users immediately to their next task. An innovative dependency tree illustrates the relationships between dependent processes.

Dynamic Explorers – MasterControl's Explorer, similar to Windows Explorer, is an easy-to-use and dynamic tool for easy search and retrieval of documents. All SOPs and other documents related to a particular change can be grouped together. Users can create virtual folders within Explorers that will automatically retrieve documents based on pre-defined queries for effective electronic regulatory submissions system.

Powerful Reporting Tool – Data can be grouped together by a date interval and then charted over a date range. For example, the number of customer complaints that have led to a change can be totaled for each week and charted for the last year. Data can be summarized in multiple levels, so change orders can be reported by product, department, root cause, etc.

Sustained Compliance – Inadequate change control can lead to serious quality system violations and expose pharmaceutical manufacturing companies to product liability actions. The MasterControl electronic regulatory submissions software is designed not only to help you attain FDA and ISO compliance – but to sustain it year after year – by interconnecting all quality subsystems, strengthening the change control procedure, fostering efficiency throughout the enterprise, and keeping compliance costs down. MasterControl offers comprehensive validation services, including protocols and consulting services. More importantly, MasterControl offers you something beyond software: a partnership that will support your compliance efforts in the long term.

For More Information about Electronic Regulatory Submissions Software Systems

For more information on how MasterControl's electronic regulatory submissions software systems can help your pharmaceutical company with its eSubmissions, please feel free to contact a MasterControl representative.

The QMS Provider for the FDA

MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.